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Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer Clinical research trials and Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer. Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer  Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
For Condition: stage 1 prostate cancer,stage 2 prostate cancer,recurrent prostate cancer,stage 3 prostate cancer
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies such as ABX-EGF can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of ABX-EGF in treating patients who have prostate cancer that has not responded to hormone therapy.
Details: OBJECTIVES: - Determine the clinical effect of monoclonal antibody ABX-EGF, determined by the PSA response, in patients with hormone-resistant prostate cancer with rising PSA values without metastasis. - Determine the pharmacokinetics and safety profile (including immunogenicity) of this drug in these patients. - Determine the overall survival of patients treated with this drug. - Determine the time to disease progression and time to PSA progression in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive monoclonal antibody ABX-EGF IV over 1 hour once weekly. Treatment continues every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years. PROJECTED ACCRUAL: Approximately 30-50 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of prostate cancer with rising PSA values without metastasis - PSA must be at least 5 ng/mL - PSA must show an increase above a reference level on 2 separate occasions - Must have tumor over-expressing epidermal growth factor receptor (EGFr) by immunohistochemistry - Staining must be 2+ or 3+ in at least 10% of evaluated tumor cells - Must have tissue available for diagnostics - Must have failed prior front-line luteinizing hormone-releasing hormone (LHRH) analogue (e.g., leuprolide or goserelin) OR failed orchiectomy and have castrate levels of testosterone (less than 50 mg/mL) NOTE: Must continue on a LHRH analogue (unless an orchiectomy was performed) throughout the study PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count greater than 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 3 times ULN - AST and ALT no greater than 3 times ULN Renal - Creatinine less then 2.2 mg/dL - Calcium no greater than ULN Cardiovascular - Left ventricular ejection fraction at least 45% by MUGA - No myocardial infarction within the past year Other - HIV negative - Fertile patients must use effective contraception during and for 1 month after study - No other malignancy within the past 5 years except basal cell carcinoma - No history of chronic medical or psychiatric condition or laboratory abnormality that would preclude study participation, administration, or interpretation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - See Disease Characteristics - At least 6 weeks since prior steroidal or nonsteroidal antiandrogens (4 weeks for flutamide) - Concurrent steroid therapy allowed as replacement therapy only Radiotherapy - Not specified Surgery - See Disease Characteristics Other - At least 30 days since prior investigational therapy - At least 30 days since prior anticancer therapy - No prior systemic therapy for prostate cancer (except hormonal therapy) - No prior anti-EGFr therapy - Concurrent antihypercalcemic treatment allowed in the presence of elevated calcium levels but not as cancer therapy for bone disease - No other concurrent anti-EGFr therapy - No other concurrent anticancer therapy - No other concurrent investigational therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ArieBelldegrun, Principal Investigator, Jonsson Comprehensive Cancer Center
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111
United States
Recruiting Louis Weiner 215-728-2480
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1738
United States
Recruiting Arie Belldegrun 310-825-1094
Additional Information:
Study ID Numbers: CDR0000269889; UCLA-0206074,ABX-0301
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054574
Other Stage 3 Prostate Cancer Studies:
1. Radiation Therapy With or Without Bicalutamide in Treating Patients With Stage II, Stage III, or Recurrent Prostate Cancer
2. APC8015 and Bevacizumab in Treating Patients With Prostate Cancer
3. Radiation Therapy in Treating Patients With Prostate Cancer
4. Neoadjuvant Exisulind in Treating Patients Who Are Undergoing Radical Prostatectomy for High-Risk Stage II or Stage III Prostate Cancer
5. Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer
Related Studies:
Other stage 3 prostate cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer
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